The present invention generally relates to implantable medical devices (IMDs) and instruments. Specifically, the invention relates to an apparatus and method that enables exchange of medically relevant data and information between a number of instruments and IMDs. More specifically, the invention pertains to passive data exchange and collection based on a plurality of instruments, which may interrogate each other and/or IMDs for the purpose of exchanging pertinent data. The system is compatible with and may operate within a network or web-enabled system for transferring the passively collected data.
After the implantation of an IMD, such as for example, a cardiac pacemaker, clinician involvement with respect to the IMD has typically only begun. The IMD cannot be implanted and forgotten, but must be monitored for appropriate operation. The IMD may also require occasional adjustment of certain parameters or settings to optimize its functionality for therapy and diagnosis. In addition, IMDs may also need to be replaced in response to or in anticipation of changes in patient condition or other environmental factors, or based on factors internal to the device, battery depletion, for example. Instruments that program the IMDs may also require firmware or software upgrades or modifications.
Further, the implantation of a medical device is an event that must be carefully documented or recorded by various clinicians and commercial entities. For example, per FDA requirements, a clinician must record information about the device such as its serial and model number in order to inform the patient of any health safety alerts, should these occur. Such information is also useful if any firmware or software updates or upgrades involving the device are to be made. These same data are necessary if the physician is to issue reminders to the patient regarding significant dates involving the IMD in order to generally aid in patient compliance. The IMD may also require regular maintenance checks, suggested or prescribed. The renewal of a power supply or the refilling of a reservoir containing a drug administered by the device are examples of routine maintenance that may be required. Similarly, the manufacturer and/or seller of the device will probably wish to match information about the device such as its serial and model number, manufacturing date, its batch or lot, with, for example, the patient receiving the implant and/or the clinical entity administering the device. Maintaining such a database ensures that any important information involving the device may be promptly provided to the FDA, the patient, and the clinician either directly or indirectly.
Further, medical practice dictates that an accurate record of past and contemporaneous programming sessions be documented. Typically, such a report identifies all the medical devices involved in any interactive procedure. Specifically, all data collected by peripheral and major instruments that downlink to the IMD may be reported. Currently, such procedures are reported only when the instrument is in direct contact with the IMD via an RF programming head. And while the data accumulated by the IMD may be uplinked to the instrument, some data requires manual entry during each procedure, for example, the model and serial number of the IMD in/on a piece of documentation. One of the limitations of this procedure is the fact that it is error prone and requires rechecking of the data to verify accuracy. The use of human clinicians and technicians to analyze data and document changes in device therapy based on clinical diagnoses also may result in inefficiencies and errors.
Thus, it may be desirable to limit clinician, technician, or other human involvement in documenting certain information about the IMD and its operation within a patient, once the IMD is implanted. For example, after implantation, the IMD must be registered, specifically by model and serial number among other pieces of required data.
There is also a need to monitor the status of the instrument/programmer on a regular, if not continuous, basis to ensure optimal patient care. In the absence of other alternatives, this imposes a great burden on the patient if a hospital or clinic is the only center where the necessary upgrade, follow up, evaluation and adjustment of the IMDs can be made. Further, even if feasible, the situation involving patients with multiple implants would require the establishment of multiple service areas or clinic centers to support the burgeoning number of multi-implant patients worldwide.
A technology-based health care system that fully integrates the technical and social aspects of patient care and therapy should be able to flawlessly connect the client with care providers irrespective of the separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted modern medical practice, developments in communications technology are making it ever more possible to provide medical services in a time and place independent manner.
The frequent use of programmers to communicate with the IMD and provide various remote services, have become an important aspect of patient care as indicated in the disclosures contained in co-pending applications titled xe2x80x9cApparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,xe2x80x9d filed on Oct. 26, 1999, Ser. No. 09/426,741; xe2x80x9cTactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,708 xe2x80x9cApparatus and Method for Automated Invoicing of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/430,208; xe2x80x9cApparatus and Method for Remote Self-Identification of Components in Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,956; xe2x80x9cApparatus and Method to Automate Remote Software Updates of Medical Device Systems,xe2x80x9d filed Oct. 29, 1999, Ser. No. 09/429,960; xe2x80x9cMethod and Apparatus to Secure Data Transfer From Medical Device Systemsxe2x80x9d filed Nov. 2, 1999, Ser. No. 09/431,881; xe2x80x9cVirtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systemsxe2x80x9d filed Dec. 17, 1999, Ser. No. 09/466,284; xe2x80x9cIntegrated Software System For Implantable Medical Device Installation and Managementxe2x80x9d filed Dec. 24, 1999, Ser. No. 60/173,082 which are all incorporated herein by reference in their entirety.
In related art, Ferek-Petric discloses a system for communication with a medical device in a co-pending application, Ser. No. 09/348,506 that is incorporated herein by reference in its entirety. The disclosure relates to a system that enables remote communications with a medical device, such as a programmer. One of the significant teachings of Ferek Petric""s disclosure, in the context of the present invention, includes the implementation of communication systems, associated with IMDs, that are compatible with the Internet. Specifically the disclosure advances the art of remote communications between a medical instrument, such as a programmer, and experts located at a remote location using the Internet. As indicated in the disclosure, the communications scheme is structured to primarily alert remote experts to existing or impending problems with the programming device so that prudent action, such as early maintenance or other remedial steps, may be timely exercised. Further, because of the early warning or advance knowledge of the problem, the remote expert would be well informed to provide remote advice or guidance to service personnel or operators at the programmer.
Accordingly, there is a need for a system in which a programmer and/or IMD could passively exchange and/or collect device, instrument related data as well as pertinent clinical data, in a secure manner, with a plurality of programmers that are in contact with an Information Network. Specifically, telemetry or equivalent wireless systems could be structured to transmit the data to any other instrument. These data could then be transferred to a remote data center where a physician or other health care specialists can take any necessary action in response to the transferred data. Such actions include but are not limited to: remote analysis of the data, suggested changes to programmed parameters, notification that the IMD has reached elective replacement status, inter alia. As discussed herein below, the present invention provides these and other means to ensure such transfer of data.
The present invention discloses an apparatus and method by which medical instruments communicate and exchange data autonomously with each other as well as with IMDs in a passive manner. Accordingly, there is no need for any human intervention to initiate the transfer of data.
In this invention, one or more IMDs, such as a pacemaker, defibrillator, drug pump, neurological stimulator, or physiological signal recorder may be deployed in a patient. The IMD is preferably equipped with a radio frequency transmitter or receiver, or an alternate wireless communication telemetry technique or media that enables signals to travel through human tissue. For example, the IMD transmission device might be a radio frequency telemetry, acoustic telemetry, or a transmission technique that uses patient tissue as a transmission medium. Alternately, an IMD may be deployed in a manner by which a transmission or receiving device is worn externally by the patient but is connected directly or via wires to the IMD. An external instrument, generally termed a programmer, is positioned outside the patient. The programmer is also equipped with a radio frequency or other communication means compatible with the communication media of the IMD or the IMD transmitter/receiver. Communication may be effected between the IMD transmitter/receiver and the external programmer, e.g. via radio frequency. The programmer is preferably connected via a wireless or direct connection communication media, such as, for example, a modem and direct dial connection, with a data network, LAN, WAN, wireless, or infrared network. The present invention includes a scheme for enabling communication between programmers at times when they are not in contact with a data network. Subsequently, when one of these programmers, comes into contact with a network, it would xe2x80x9cbubble upxe2x80x9d data that was previously exchanged between the programmers in a passive manner.
One of the other distinguishing features of this invention includes the use of a highly flexible and adaptable communications scheme to promote real-time communications between a programmer and a plurality of co-implanted medical devices (CIMDs). The CIMDs are structured to share information intracorporeally and may interact with the programmer, as a unit. Specifically, the CIMDs either jointly or severally can be interrogated to implement or extract clinical information as required. In other words, all of the CIMDs may be accessed via one IMD or, alternatively, each one of the CIMDs may be accessed individually. The information collected in this manner may be transferred to the programmer by up linking the IMDs as needed.
In one embodiment of the present invention, instruments/programmers in close proximity with each other could exchange and transfer small files. Such files could be, for example, the form of audit files consisting of very short text files containing model and serial number, software revision number, date and time stamp of the transaction. Subsequently, when either programmer is connected to the main server, termed the Medtronic Information Network (MIN), these audit files are uploaded to the server. These data might reveal, for example, that one of the instrument/programmers did not have the most current software revision. When this information is uploaded to the MIN, the institution who xe2x80x9cownsxe2x80x9d the instrument will be automatically notified of this fact and advised to have the software updated. Thus, the passive collection of these and subsequent data assists in maintaining compliance with the FDA""s traceability standards for medical instruments and IMDs.
In a similar fashion, this passive method of data collection may also be used to upload IMD and patient data through the system and, ultimately, to the MIN, as generally disclosed in U.S. Pat. No. 5,752,976 issued to Duffin, et al., incorporated herein by reference in its entirety. The goal of the complete system is to have IMD and patient data available on one server, with immediate access to physicians and clinicians anytime and anywhere. One of the critical elements is to have all these data resident on the MIN, so that they can be distributed to medical personnel if and when requested. Consistent with the system disclosed in the ""976 patent, clinicians may have to alter their accustomed protocol. Compliance may be difficult to some and, as a result, there may be occasions when relevant data is not uploaded to the MIN. In such cases, passive data collection will ensure that such a transfer will ultimately occur. If the patient is at home and is using a home monitoring system, pertinent data not uploaded but relevant to the IMD and/or the patient will be automatically uploaded either transtelephonically or by wireless technology. On the other hand, when the patient visits the clinic, these data may be automatically transferred to the programmer either during device interrogation or by wireless technology, e.g., Blue Tooth, Telemetry C, even if the patient is seated in the waiting room to see another type of physician for a complaint not related to the IMD. The next time the clinic programmer uplinks to the MIN, all passively collected data is uploaded. The number of such data collections that any one programmer/instrument can store is limited only by the instrument""s nonvolatile memory size. The server will automatically erase these data from the instrument""s memory upon confirmation of successful receipt.
Another application of this passive collection of pertinent data involves xe2x80x9cmissingxe2x80x9d instruments. Occasionally, an instrument may be placed in temporary storage within a medical institution and then its location is forgotten. In one possible scenario, one can imagine the xe2x80x9cmissingxe2x80x9d instrument is located in a storage room behind a door that opens up on a main hallway. In accordance with the present invention, all instruments/programmers include an interogable sleep mode that is activated when the programmer is not directly connected to a power source. Thus when a clinician, physician, or manufacturer""s representative is transporting or carrying another instrument along this hallway and passes the storage room. The moving instrument would xe2x80x9cdiscoverxe2x80x9d the missing instrument in the storage room as it passes along the hallway. All the pertinent data files would be transferred to the moving instrument from which they would be uploaded the next time that instrument is in contact with the MIN. The network software would, in turn, inter alia, notify the institution and Medtronic of the device""s approximate location as well as any pertinent need, such as updated software.
In another scenario, one can envision an instrument being transported through an airport by a clinician, physician, or more probably a manufacturer""s representative. With the passive data collection feature turned on, that instrument might perform a passive data collection transaction with a traveling patient""s IMD. These data might include the previously mentioned simple audit file along with more important information, for example, the date and time that an unreported elective replacement indicator (ERI) was tripped. Again, the next time this instrument is in contact with the MIN, these data would be uploaded to the server. The server""s software, in turn, would be scanning for pertinent data such as the ERI and, if located, send the patient""s physician notification of that fact. Patient data, however, would be encrypted to protect the patient""s privacy.
The apparatus and method disclosed in the present invention should not be thought of as limited by the data transfer rate of currently available wireless technology. As technology advances and wireless transmission rates such as for example, the use of broad band, increase this same passive data collection method will allow the transfer of very large amounts of data.
The present invention will now be described with reference to the following drawings, in which like reference numbers denote the same element throughout.